薬物疫学と医薬品の安全性の進歩

概要

Pharmacovigilance and Risk Management

Ryan Zia Arslaan

Pharmacovigilance (PV or PhV), also referred to as drug safety, is that the pharmacological science concerning the gathering, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to stay watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the newest amendment of the applicable legislation). Medication errors like overdose, and misuse and abuse of a drug also as drug exposure during pregnancy and breastfeeding, also are of interest, even without an adverse event, because they'll end in an adverse drug reaction.